by Xilin Wang
Xilin Wang, Comprehensive Surveys on Validating Wearable ECG Devices and Related FDA’s SaMD Regulating Development, Winter 2021 Int’l J. L. Ethics Tech. 94(2021).
Available at: https://doi.org/10.55574/SQRS7690
Author Information: Student, Brown University
Abstract: Wearable technology is becoming more and more popular because of its convenience and accessibility, especially in connected health. Machine Learning algorithms are proven to be a practical approach in improving the accuracy of wearable technology. Recently, the FDA has established several goals of regulating AI/ML-based Software as a Medical Device (SaMD) to validate products before applying in a clinical setting thoroughly. This review comprehensively analyzes studies validating different wearable devices and algorithms conforming to the FDA standards and discusses the potential consequences of wearable devices’ usage. We find an acceptable accuracy for the devices and the need for further investigation into this technology.
Keywords: SaMD, Medical AI, administrative law, wearable technology, ECG
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Attribution 4.0 International (CC BY 4.0)
Persistent link: https://www.ijlet.org/w202194/
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